                             SUPPORTING STATEMENT
	ENVIRONMENTAL PROTECTION AGENCY
	
NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal)

1.  Identification of the Information Collection

      1(a)  Title of the Information Collection

NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal), EPA ICR Number 1730.09, OMB Control Number 2060-0363 

      1(b)  Short Characterization/Abstract

      The New Source Performance Standards (NSPS) for Hospital/Medical/ Infectious Waste Incinerators (HMIWI) were promulgated on September 15, 1997, and amended on October 6, 2009.  The original standards applied to owners or operators of HMIWI for which construction commenced after June 20, 1996, or for which modification commenced after March 16, 1998, but no later than April 6, 2010.  Sources subject to the original standards are now covered under the revised Emission Guidelines for HMIWI at 40 CFR part 60, subpart Ce.  This information request covers the reporting and recordkeeping requirements associated with the revised NSPS, which apply to new facilities only.  New facilities include those that commenced construction after December 1, 2008 or commenced modification after April 6, 2010.  This information is being collected to assure compliance with 40 CFR part 60, subpart Ec.

      In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities.  They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction           in the operation of an affected facility, or any period during which the monitoring system is inoperative.  These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

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      Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records.  All reports are sent to the delegated state or local authority.   In the event that there is no such delegated authority, the reports are sent directly to the U. S. Environmental Protection Agency (EPA) regional office.
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        Based on our consultations with industry representatives, there is an average of one affected facility at each plant site and that each plant site has only one respondent (i.e., the owner/operator of the plant site).
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      Over the next three years, an average of five respondents per year will be subject to the standards, and one additional respondent per year will become subject to the standards.
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      The Office of Management and Budget (OMB) approved the current ICR without any "Terms of Clearance". 
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	The "Affected Public" is owners and operators of HMIWI subject to the revised NSPS.  The burden to the "Affected Public" may be found below in Table 1: Annual Respondent Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).  The burden to the "Federal Government" is attributed entirely to work performed by federal employees or government contractors; this burden is found below in   Table 2: Average Annual EPA Burden and Cost  -  NSPS for Hospital/Medical/ Infectious   Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal). 

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2.  Need for and Use of the Collection
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      2(a)  Need/Authority for the Collection
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      The EPA is charged under Section 111 of the Clean Air Act (CAA), as amended, to establish standards of performance for new stationary sources that reflect: 
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            . . . application of the best technological system of continuous emissions reduction which (taking into consideration the cost of achieving such emissions reduction, or any non-air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated.  Section 111(a)(l).
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The Agency refers to this charge as selecting the best demonstrated technology (BDT).  Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years. 
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      In addition, section 114(a) states that the Administrator may require any owner/operator subject to any requirement of this Act to: 
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            (A) Establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); (E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; (F) submit compliance certifications in accordance with Section 114(a)(3); and (G) provide such other information as the Administrator may reasonably require. 
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      In the Administrator's judgment, dioxin/furan, particulate matter (PM), carbon monoxide (CO), hydrogen chloride (HCl), sulfur dioxide (SO2), nitrogen oxides (NOx), lead (Pb), cadmium (Cd), and mercury (Hg) emissions from HMIWI either cause or contribute to air pollution that may reasonably be anticipated to endanger either public health or welfare.  Therefore, the NSPS were promulgated for this source category at 40 CFR part 60, subpart Ec.
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      2(b)  Practical Utility/Users of the Data
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      The recordkeeping and reporting requirements in the standard ensure compliance        with the applicable regulations which where promulgated in accordance with the Clean Air    Act.  The collected information is also used for targeting inspections and as evidence in legal proceedings.
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      Performance tests are required in order to determine an affected facility's initial capability to comply with the emission standard. Continuous emission monitors are used to ensure compliance with the standard at all times.
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      The notifications required in the standard are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations.  The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and leaks are being detected and repaired and the standard are being met.  The performance test may also be observed.
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      The required semiannual reports are used to determine periods of excess emissions, identify problems at the facility, verify operation/maintenance procedures and for compliance determinations.
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3.  Non-duplication, Consultations, and Other Collection Criteria
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      The requested recordkeeping and reporting are required under 40 CFR part 60,       subpart Ec.
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      3(a)  Non-duplication
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       If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office.  Otherwise, the information is sent directly to the delegated state or local agency.  If a state or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards.  Therefore,  duplication does not exist.
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      3(b)  Public Notice Required Prior to ICR Submission to OMB
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      An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (77 FR 47631) on August 9, 2012.  No comments were received on the burden published in the Federal Register.
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      3(c)  Consultations

      The Agency has consulted industry experts and internal data sources to project the number of affected facilities and industry growth over the next three years.  The primary source of information as reported by industry, in compliance with the recordkeeping and reporting provisions in the standard, is the Online Tracking Information System (OTIS) which is operated and maintained by EPA's Office of Compliance.  OTIS is EPA's database for the collection, maintenance, and retrieval of all compliance data.  The growth rate for the industry is based on our consultations with the Agency's internal industry experts. 

      Industry trade associations and other interested parties were provided an opportunity to comment on the burden associated with the standard as it was being developed and the standard has been previously reviewed to determine the minimum information needed for compliance purposes.  In developing this ICR, we contacted: 1) St. Joseph's Hospital, at (813) 870-4000;  and 2) the Wilkes-Barre General Hospital, at (570) 829-8111.

      It is our policy to respond after a thorough review of comments received since the last ICR renewal as well as those submitted in response to the first Federal Register notice.  
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      3(d)  Effects of Less Frequent Collection
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      Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards.  Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices   are applied and emission limitations are met.  If the information required by these standards    was collected less frequently, the proper operation and maintenance of control equipment and  the possibility of detecting violations would be less likely.
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      3(e)  General Guidelines
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      These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR part 1320, section 1320.5.
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      These standards require the respondents to maintain all records, including reports and notifications for at least five years.  This is consistent with the General Provisions as applied to the standards.  EPA believes that the five-year records retention requirement is consistent the Part 70 permit program and the five-year statute of limitations on which the permit program is based.  The retention of records for five years allows EPA to establish the compliance history of a source, any pattern of non-compliance and to determine the appropriate level of enforcement action.  EPA has found that the most flagrant violators have violations extending beyond five years.  In addition, EPA would be prevented from pursuing the violators due to the destruction  or the non-existence of essential records.
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      3(f)  Confidentiality
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      Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, subpart B - Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September    20, 1978; 44 FR 17674, March 23, 1979).
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      3(g)  Sensitive Questions
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      The reporting or recordkeeping requirements in the standard do not include sensitive questions.
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4.  The Respondents and the Information Requested
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      4(a)  Respondents/SIC Codes
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      The respondents to the recordkeeping and reporting requirements are owners and operators of HMIWI.  The United States Standard Industrial Classification (SIC) codes for the respondents affected by the standards, which corresponds to the North American Industry Classification System (NAICS) codes, are listed below for this source category.
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Standard (40 CFR Part 60, Subpart Ec)
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SIC Codes
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NAICS Codes
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General Medical and Surgical Hospitals
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8062
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622110
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Specialty Hospitals
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8069
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622310
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Medicinal and Botanical Manufacturing
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2833
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325411
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Pharmaceutical Preparation Manufacturing
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2834
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325412
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Solid Waste Combustors and Incinerators
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4953
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562213
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Colleges, Universities, and Professional Schools
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8221
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611310
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Research and Development in Physical, Chemical, and Life Sciences
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8731, 8733
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541710
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National Security
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9711
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928110
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Public Health Facility
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9431
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923120
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      4(b)  Information Requested
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            (i)  Data Items
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      In this ICR, all the data that is recorded or reported is required by NSPS for Hospital/ Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec).  
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      A source must make the following reports:
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Notifications
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Notification and application of construction or modification
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60.58c(a), 60.7(a)
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Notification of anticipated startup
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60.58c(a), 60.7(a)
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Notification of actual startup
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60.7(a)
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Notification of type(s) of waste to be combusted
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60.58c(a)(2)(i)
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Notification of HMIWI capacity
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60.58c(a)(2)(ii)
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Notification of initial continuous monitoring system (CMS) demonstration (including CO CEMS)
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60.7(a)
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Notification of initial performance test
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60.8(d)
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Notification of exemption claim for combustors burning pathological, low-level radioactive, and/or chemotherapeutic waste
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60.50c(b)(1)
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Notification of exemption claim for co-fired combustors
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60.50c(c)(1)
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Reports
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Statement of intent to construct/modify
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60.58c(a)(1)(i)
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Documentation produced as a result of the siting requirements
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60.58c(a)(1)(iv), 60.54c(c)
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Waste management plan
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60.58c(c)(3), 60.55c
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Analysis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection systems
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60.58c(c)(4)
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Report of initial performance tests
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60.58c(d)(6), 60.8(a)
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Initial report of values for site-specific operating parameters
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60.58c(c)(2), 60.7(a)
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Annual report of values for site-specific operating parameters
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60.58c(d)(1)
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Annual and semiannual reports of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained
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60.58c(d), 60.58c(e), 60.7(c)
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Annual report of no excess emissions
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60.58c(d)(7), 60.7(c)
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Report of results of annual performance test
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60.58c(d)(6)
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Annual report of control equipment inspection
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60.58c(d)
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      A source must keep the following records:
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Recordkeeping
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Retention of records for 5 years
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60.58c(b)
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Records of startup, shutdown, or malfunction
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60.7(b)
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Documentation produced as a result of siting requirements
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60.58c(b)(7)
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Records of operators completing review of HMIWI operating manual
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60.58c(b)(8)
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Records of operators completing operator training course and qualification requirements
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60.58c(b)(9)-(10)
Records of initial and annual testing of fugitive ash emissions
60.58c(b)(2)(ii)
Records of process and control device operating parameters
60.58c(b)(2)(iii)(xix)
Records of CMS operation and maintenance (including CO CEMS)
60.7(f)
Records of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained
60.58c(b)(3)-(5)
Records of initial, annual, and any subsequent performance tests
60.58c(b)(6)
Records of calibration of monitoring devices (including CO CEMS)
60.58c(b)(11)
Records of annual control equipment inspections, required maintenance, and repairs not completed during established timeframe
60.58c(b)(2)(xvii)
Records of bag leak detection system alarms and corrective action taken
60.58c(b)(2)(xviii)
Records of CO concentrations from CO CEMS
60.58c(b)(2)(xix)
Records on quarterly basis of types and amounts of materials charged for co-fired combustors and for incinerators burning only pathological, low-level radioactive, and/or chemotherapeutical waste
60.50c(b), (c)
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Electronic Reporting
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      Some of the respondents are using monitoring equipment that automatically records parameter data.  Although personnel at the affected facility must still evaluate the data, internal automation has significantly reduced the burden associated with monitoring and recordkeeping at a plant site. 
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      Also, regulatory agencies in cooperation with the respondents continue to create reporting systems to transmit data electronically.  However, electronic reporting systems are still not widely used.  At this time, it is estimated that approximately 10 percent of the respondents use electronic reporting.
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            (ii)  Respondent Activities	
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Respondent Activities
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Read instructions.
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Perform CMS demonstrations and repeat CMS demonstrations if necessary.
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Perform performance tests and repeat performance tests if necessary.
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Develop, update, and review operating information.
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Perform control equipment inspections.
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Prepare and submit the notifications and reports listed in the table above.
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Develop waste management plan.
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Prepare and review reports of performance tests.
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Prepare and review reports of CMS demonstrations.
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Document siting requirements.
Complete operator training and qualification.
Maintain the records listed in the table above.
Train personnel.
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      Currently sources are using monitoring and reporting equipment that provide parameter data in an automated way e.g., continuous parameter monitoring system.  Although personnel    at the source still need to evaluate the data, this type of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping. 
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5.  The Information Collected:  Agency Activities, Collection Methodology, and Information Management
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      5(a)  Agency Activities
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      EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.
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Agency Activities
Observe initial performance tests and repeat performance tests if necessary.
Observe enforcement activities (retesting) related to excess emissions.
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Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.
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Audit facility records.
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Input, analyze, and maintain data in the Online Tracking Information System (OTIS). 
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      5(b)  Collection Methodology and Management
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      Following notification of startup, the reviewing authority could inspect the source          to determine whether the pollution control devices are properly installed and operated.  Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.
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      Information contained in the reports is entered into OTIS which is operated and maintained by EPA's Office of Compliance.  OTIS is EPA's database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government-owned facilities.  EPA uses the OTIS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters.  EPA and its delegated Authorities can edit, store, retrieve and analyze the data.
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       The records required by this regulation must be retained by the owner/operator for five years.
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      5(c)  Small Entity Flexibility
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	There are no small entities (i.e., small businesses) affected by this regulation. However, the impact on small entities (i.e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities.  The Agency considers these to be the minimum requirements needed to ensure compliance and, therefore, cannot reduce them further for small entities.  However, the regulation includes various provisions that would reduce the burden on HMIWI, including small entities.  For example, there are provisions allowing HMIWI to skip annual tests and test reports for the two-year periods if they have demonstrated compliance for three annual tests in a row.
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      5(d)  Collection Schedule
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      The specific frequency for each information collection activity within this request is shown in below Table 1: Annual Respondent Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
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6.  Estimating the Burden and Cost of the Collection
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      Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR.  The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act.  Wherever appropriate, specific tasks and major assumptions have been identified.  Responses to this information collection are mandatory.
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      The Agency may not conduct or sponsor, and a person is not required to respond to,        a collection of information unless it displays a currently valid OMB Control Number.
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      6(a)  Estimating Respondent Burden
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      The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 3,912 (Total Labor Hours from Table 1 below).   These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.
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      6(b)  Estimating Respondent Costs
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            (i)  Estimating Labor Costs 
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      This ICR uses the following labor rates: 
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            Managerial	$121.44 ($57.83+ 110%)   
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            Technical	$100.23 ($47.73 + 110%)
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            Clerical	$50.51 ($24.05 + 110%)
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These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2012, "Table 2. Civilian Workers, by occupational and industry group."  The rates are from column 1, "Total compensation."  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.
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             (ii)  Estimating Capital/Startup and Operation and Maintenance Costs
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      The type of industry costs associated with the information collection activities in the subject standard are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring.  The capital/startup costs are one time costs when a facility becomes subject to the regulation.  The annual operation and maintenance costs are the ongoing costs to maintain the monitors and other costs such as photocopying and postage.
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            (iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs
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Capital/Startup vs. Operation and Maintenance (O&M) Costs
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(A)
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Continuous Monitoring Device
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(B)
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Capital/Startup Cost for One Respondent
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(C)
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Number of New Respondents
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(D)
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Total Capital/Startup Cost,  (B X C)
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(E)
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Annual O&M Costs for One Respondent
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(F)
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Number of Respondents  with O&M
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(G)
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Total O&M,
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(E X F)
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DIFF/WS
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$1,233
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1
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$1,233
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$4,733
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5
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$23,665
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DIFF
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$967
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1
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$967
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$2,733
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5
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$13,665
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WS
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$1,233
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1
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$1,233
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$1,133
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5
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$5,665
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SNCR
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$1,400
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1
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$1,400
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$300
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5
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$1,500
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CO CEMS
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$17,500
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1
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$17,500
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$25,100
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5
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$125,500
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BLD
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$1,033
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1
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$1,033
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$1,267
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5
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$6,335
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ACI
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$0
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1
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$0
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$3,367
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5
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$16,835
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Testing
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$67,458
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1
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$67,458
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$0
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5
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$0
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Filing Cabinets
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$100
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1
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$100
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$0
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5
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$0
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Photocopying
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$0
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1
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$0
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$199
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5
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$995
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Postage
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$0
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1
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$0
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$93
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5
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$465
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TOTAL
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$90,924
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1
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$90,924
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$38.925
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5
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$194,625
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 Note: The capital and O&M costs per respondent represents the average cost of large, medium, and small units. 
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      The total capital/startup costs for this ICR are $90,924.  This is the total of column D in the above table. 
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      The total operation and maintenance (O&M) costs for this ICR are $194,625.  This is the total of column G. 
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      The average annual cost for capital/startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $285,549.   These are the costs of recordkeeping.  
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      6(c)  Estimating Agency Burden and Cost
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      The only costs to the Agency are those costs associated with analysis of the reported information.  EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information. 
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      The average annual Agency cost during the three years of the ICR is estimated to be $16,717.  
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      This cost is based on the average hourly labor rate as follows:

		Managerial	$62.27 (GS-13, Step 5, $38.92 + 60%) 
		Technical	$46.21 (GS-12, Step 1, $28.88 + 60%)
		Clerical	$25.01 (GS-6, Step 3, $15.63 + 60%)
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These rates are from the Office of Personnel Management (OPM), 2012 General Schedule, which excludes locality, rates of pay.  The rates have been increased by 60 percent to account for the benefit packages available to government employees.  Details upon which this estimate is based appear below in Table 2: Average Annual EPA Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
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      6(d)  Estimating the Respondent Universe and Total Burden and Costs
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      Based on our research for this ICR, on average over the next three years, approximately five existing respondents will be subject to the standards.  It is estimated that, after the initial year of each three-year cycle, one additional respondent per year will become subject to these same standards.  The overall average number of respondents, as shown in the table below, is five per year.
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      The number of respondents is calculated using the following table that addresses the three years covered by this ICR.  
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Number of Respondents
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Year
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(A)
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Number of New Respondents [1]
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(B)
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Number of Existing Respondents
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(C)
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Number of Existing  Respondents that keep records but do not submit reports
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(D)
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Number of Existing Respondents That Are Also New Respondents
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(E)
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Number of Respondents
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(E=A+B+C-D)
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1
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1
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3
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0
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0
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4
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2
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1
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4
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0
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0
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5
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3
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1
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5
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0
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0
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6
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Average
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1
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4
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0
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0
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5
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[1]New respondents include sources with constructed, reconstructed and modified affected facilities.
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      Column D is subtracted to avoid double-counting respondents.  As shown above, the average Number of Respondents over the three year period of this ICR is five. 
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      The total number of annual responses per year is calculated using the following table: 
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                            Total Annual Responses
                                      (A)
                        Information Collection Activity
                                      (B)
                             Number of respondents
                                      (C)
                              Number of responses
                                      (D)
       Number of respondents that keep records but do not submit reports
                                      (E)
                            Total annual responses
                                E = (B x C) + D
Notification of intent to construct
                                       1
                                       1
                                      N/A
                                       1
Notification of anticipated commencement of construction
                                       1
                                       1
                                      N/A
                                       1
Notification of anticipated startup
                                       1
                                       1
                                      N/A
                                       1
Notification of actual startup
                                       1
                                       1
                                      N/A
                                       1
Notification of type(s) of waste to be combusted
                                       1
                                       1
                                      N/A
                                       1
Notification of HMIWI capacity
                                       1
                                       1
                                      N/A
                                       1
Notification of initial performance test
                                       1
                                       1
                                      N/A
                                       1
Notification of initial CMS demonstration
                                       1
                                       1
                                      N/A
                                       1
Initial report for the site selection analysis
                                       1
                                       1
                                      N/A
                                       1
Waste management plan
                                       1
                                       1
                                      N/A
                                       1
Analysis and supporting documentation demonstrating conformance with EPA guidance and specifications for bag leak detection systems
                                      0.7
                                       1
                                      N/A
                                      0.7
Report of initial performance test
                                       1
                                       1
                                      N/A
                                       1
Report of initial CMS demonstration
                                       1
                                       1
                                      N/A
                                       1
Annual report
                                       
                                       
                                       
                                       
  CMS emissions and operating parameters
                                       5
                                       1
                                      N/A
                                       5
  Exceedances, malfunctions, and periods for which data not obtained
                                       1
                                       1
                                      N/A
                                       1
  Results of performance tests conducted during the year
                                       5
                                       1
                                      N/A
                                       5
  Report of no exceedances
                                       4
                                       1
                                      N/A
                                       4
  Report of annual control equipment inspection
                                       5
                                       1
                                      N/A
                                       5
Semiannual report of exceedances, malfunctions, and periods for which data not obtained 
                                       1
                                       1
                                      N/A
                                       1
 Total
                                       
                                       
                                       
                                     33.7
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      The number of Total Annual Responses is 34.  
--------------------------------------------------------------------------------
      
--------------------------------------------------------------------------------
      The total annual labor costs are $378,826.  Details regarding these estimates may be found below in Table 1: Annual Respondent Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
--------------------------------------------------------------------------------
      
--------------------------------------------------------------------------------
      6(e)  Bottom Line Burden Hours and Cost Tables
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2 below, respectively, and summarized below.  
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
            (i) Respondent Tally
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      The total annual labor hours are 3,912 at a cost of $378,826.  Details regarding these estimates may be found below in Table 1: Annual Respondent Burden and Cost  -  NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).  
--------------------------------------------------------------------------------
      
--------------------------------------------------------------------------------
      Furthermore, both the annual public reporting and recordkeeping burdens for this collection of information is estimated to average 115 hours per response.
--------------------------------------------------------------------------------
      
--------------------------------------------------------------------------------
      The total annual capital/startup and O&M costs to the regulated entity are $285,549.  The cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs.
--------------------------------------------------------------------------------
                  
--------------------------------------------------------------------------------
            (ii) The Agency Tally
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      The average annual Agency burden and cost over next three years is estimated to be 371 labor hours at a cost of $16,717.  See below Table 2: Average Annual EPA Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60, Subpart Ec) (Renewal).
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      6(f)  Reasons for Change in Burden
--------------------------------------------------------------------------------

       There is an adjustment increase in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens; however, this increase is not due to any program changes.  Instead, the change in the burden and cost estimates occurred because the revised standard has been in effect for more than three years and the requirements are different during initial compliance for new facilities as compared to on-going compliance for existing facilities.  The previous ICR reflected those burdens and costs associated with the initial activities for subject facilities.  This includes purchasing monitoring equipment, conducting performance tests and establishing recordkeeping systems.  This ICR reflects the on-going burden and costs for existing facilities.  Activities for existing source include both the continuously monitoring of pollutants and the submission of semiannual reports.  In addition, there are a number of new facilities that are accounted in the initial compliance phase, as described above.  The overall result is an increase in: burden hours, labor costs, and O&M costs.  Furthermore, a portion of the labor cost increase is a result of increased labor rates.  This ICR uses updated labor rates from the Bureau of Labor Statistics in order to calculate burden costs. 
      
      Additionally, there is an adjustment decrease in capital costs in this ICR compared to the previous ICR.  This is not due to any program changes.  The previous ICR assumed all capital costs associated with monitoring were incurred during a single year.  By contrast, this ICR calculates the average capital costs for new sources for each year covered under the ICR. 
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      
--------------------------------------------------------------------------------
      6(g)  Burden Statement
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      The annual public reporting and recordkeeping burdens for this collection of information is estimated to average 115 hours per response.  "Burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
      An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number.  The OMB Control Numbers for EPA regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2012-0502.  An electronic version of the public docket is available at http://www.regulations.gov/ which may be used to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the docket ID number identified in this document.  The documents are also available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the docket center is (202) 566-1752.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OECA-2012-0502 and OMB Control Number 2060-0363 in any correspondence. 

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this information.

Table 1: Annual Respondent Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60,
 Subpart Ec) (Renewal)

                                  Burden item
                        (A)
Person hours per occurrence
                (B)
No. of occurrences per respondent per year
               (C)
Person hours per respondent per year
(C=AxB)
                         (D)
Respondents per year  [a]
                 (E)
Technical person- hours per year
(E=CxD)
                 (F)
Management person hours per year
(Ex0.05)
                  (G)
Clerical person hours per year
(Ex0.1)
                          (H)
Total Cost
Per year [b]
1.  Applications
                                      N/A
 
                                       
                                       
                                       
                                       
                                       
                                                                              
2.  Survey and Studies
                                      N/A
 
                                       
                                       
                                       
                                       
                                       
                                                                              
3.  Reporting requirements
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     A.  Read instructions
                                       1
                                       1
                                       1
                                       1
                                       1
                                     0.05
                                      0.1
                                                                       $111.35 
     B.  Required activities
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
        Performance spec tests (certif.) for CMS [c]
                                      16
                                       1
                                      16
                                       1
                                      16
                                      0.8
                                      1.6
                                                                     $1,781.65 
        Repeat performance spec tests (certif.) for CMS [c,] [d]
                                      16
                                       1
                                      16
                                       0
                                       0
                                       0
                                       0
                                                                            $0 
        Development of operating information [e]
                                      160
                                       1
                                      160
                                       1
                                      160
                                       8
                                      16
                                                                    $17,816.48 
        Annual update of operating information [f]
                                      20
                                       1
                                      20
                                       5
                                      100
                                       5
                                      10
                                                                     $11,135.30
        Review of operating information with each operator  [g,] [h]
                                       8
                                       2
                                      16
                                       5
                                      80
                                       4
                                       8
                                                                     $8,908.24 
        Initial control equipment inspection [i]
                                      20
                                       1
                                      20
                                       1
                                      20
                                       1
                                       2
                                                                     $2,227.06 
        Annual control equipment inspection [i]
                                      20
                                       1
                                      20
                                       5
                                      100
                                       5
                                      10
                                                                    $11,135.30 
     C. Create information
                                    See 3B
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     D. Gather existing information
                                    See 3B
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     E. Write reports
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
          Notification of intent to construct
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of anticipated commencement of 
          construction [g]
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of anticipated startup [g]
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of actual startup [g]
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of type(s) of waste to be combusted
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of HMIWI capacity
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of initial performance test [h]
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Notification of initial CMS demonstration
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $222.71 
          Initial report for the site selection analysis [j]
                                      460
                                       1
                                      460
                                       1
                                      460
                                      23
                                      46
                                                                    $51,222.38 
          Waste management plan [k]
                                      160
                                       1
                                      160
                                       1
                                      160
                                       8
                                      16
                                                                    $17,816.48 
          Analysis and supporting documentation 
          demonstrating conformance with EPA guidance 
          and specifications for bag leak detection systems [l]
                                      40
                                       1
                                      40
                                      0.7
                                      28
                                      1.4
                                      2.8
                                                                     $3,117.88 
          Report of initial performance test [m]
                                       8
                                       1
                                       8
                                       1
                                       8
                                      0.4
                                      0.8
                                                                       $890.82 
          Report of initial CMS demonstration [m]
                                    See 3B
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
         Annual report
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
                 CMS emissions/operation parameters [n]
                                      32
                                       1
                                      32
                                       5
                                      160
                                       8
                                      16
                                                                    $17,816.48 
                 Exceedances/ malfunctions/periods of which 
                 data not obtained [o][,] [p]
                                      48
                                       1
                                      48
                                       1
                                      48
                                      2.4
                                      4.8
                                                                     $5,344.94 
                 Results of performance tests conducted 
                 during the year [q]
                                      40
                                       1
                                      40
                                       5
                                      200
                                      10
                                      20
                                                                    $22,270.60 
                Report of no exceedances [o][,] [p]
                                      24
                                       1
                                      24
                                       4
                                      96
                                      4.8
                                      9.6
                                                                    $10,689.89 
                Report of annual control equipment inspection 
                                    See 3B
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
         Semiannual report of exceedances/ 
         malfunctions/periods for which data not obtained 
         [q,] [p,] [r]
                                      48
                                       1
                                      48
                                       1
                                      48
                                      2.4
                                      4.8
                                                                     $5,344.94 
Subtotal  for Reporting  Requirements
                                       
                                       
                                       
                                       
                                   1,956.15
                                                                    $189,411.47
4.  Recordkeeping requirements
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     A. Read instructions
                                    See 3A
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     B. Plan activities
                                      N/A
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     C. Implement activities
                                      N/A
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     D. Develop record system
                                      N/A
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
     E. Time to enter information
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
          Documentation produced as a result of sitting 
          requirements
                                    See 3E
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
          Records of operators completing operator training 
          requirements [h]
                                       2
                                       2
                                       4
                                       1
                                       4
                                      0.2
                                      0.4
                                                                       $445.41 
          Records of operators that have been qualified as 
          HMIWI operators [h]
                                       2
                                       2
                                       4
                                       1
                                       4
                                      0.2
                                      0.4
                                                                       $445.41 
          Records of initial performance test
                                    See 3E
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
          Records of startup, shutdown, or malfunction
                                      1.5
                                      52
                                      78
                                       5
                                      390
                                     19.5
                                      39
                                                                    $43,427.67 
          Records of persons completing review of 
          operating information [h]
                                       2
                                       2
                                       4
                                       5
                                      20
                                       1
                                       2
                                                                     $2,227.06 
          Records of process and control device operating 
          parameters
                                      1.5
                                      52
                                      78
                                       5
                                      390
                                     19.5
                                      39
                                                                    $43,427.67 
          Records of CMS operation and maintenance [s]
                                     0.03
                                      365
                                     9.13
                                       5
                                     45.63
                                     2.28
                                     4.56
                                                                     $5,080.48 
          Records of exceedances/malfunctions/periods for 
          which data not obtained
                                      1.5
                                      52
                                      78
                                       5
                                      390
                                     19.5
                                      39
                                                                    $43,427.67 
          Records of annual and any subsequent compliance
          tests
                                    See 3E
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
          Records of annual control equipment inspections
                                    See 3B
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
          Records of bag leak detection system alarms [l]
                                      1.5
                                      52
                                      78
                                      3.3
                                     257.4
                                     12.9
                                     25.7
                                                                    $28,662.26 
     F. Time to train personnel [t]
                                      40
                                       1
                                      40
                                       5
                                      200
                                      10
                                      20
                                                                    $22,270.60 
     F. Time for audits
                                      N/A
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
Subtotal  for Recordkeeping Requirements  
                                       
                                       
                                       
                                       
                                   1,956.17
                                                                    $189,414.23
TOTAL LABOR BURDEN AND COST(rounded)
 
 
 
 
                                     3,912
                                                                      $378,826 

Assumptions:
[a] We have assumed that the average number  of sources that will be subject to the standard will be 5.  There will be one additional new source per year that will become subject to the rule over the three-year period of this ICR 
[b] This ICR uses the following labor rates:  $121.44 per hour for Executive, Administrative, and Managerial labor; $100.23 per hour for Technical labor, and $50.51
per hour for Clerical labor.  These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2012 " Table 2. Civilian Workers, by occupational and industry group."  The rates are from column 1,'Total compensation."  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.
[c] We assume that  performance specification to certify CMS is expected to take approximately 16 hours.
[d] We assume no failures of the initial CMS demonstrations; includes CO CEMS.
[e] We assume it will take160 hrs to develop the operating information.
[f] We assume that it will take 20 hours to update the operating information each year.  
[g] We assume that it will take 8 hours to review the operating information with each operator.
[h] We assume that it will take 2 operators per facility to enter information.  Also assume there is no operator turnover at the affected facilities. 
[i] We assume that annual control equipment inspection will occur for all sources. 
[j] We assume that it will take 460 hours to develop the site selection analysis.
[k] We assume that it will take 160 hours to develop the waste management plan.
[l]  We assume that it will take 40 hours to develop the bag leak detection system analysis and 1.5 hours to record bag leak detection system alarms.  Assume the total number of sources will be evenly distributed among small, medium, and large sources and only new large and medium sources (i.e. two-thirds of the effected sources) will install baghouses.
[m] We assume that it will take 8 hours for each facility to review the report of the initial performance test for pollutants and fugitive ash.
[n] Person-hours per occurrence are assumed to be 32 hours.
[o] We have assume that it will take 48 hours and 24 hours per report per affected facility to report monitoring exceedances and no excess emissions, respectively.  Because testing and monitoring requirements focus primarily on three pollutants (PM, CO, and HCl), assume three pollutants.
[p] Assume 20 percent of respondents report monitoring exceedances and 80 percent report no excess emissions.
[q] Assume 40 hours to review report of annual compliance test.
[r] Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods for which data were not obtained, the frequency of the semiannual report is shown in the table as only once per year to avoid double-counting.
[s] We assume that this activity will be recorded daily.
[t] We assumed that it will take 40 hours once per year to train one person to perform the Method 9 and Method 22 tests.  The labor requirements to train the personnel were estimated to be 8 hr/d for 5 d/yr.

















Table 2: Average Annual EPA Burden and Cost  -  NSPS for Hospital/Medical/ Infectious Waste Incinerators (40 CFR Part 60,
 Subpart Ec) (Renewal)

                                   Activity
                      (A)
EPA Person hours per occurrence
                (B)
No. of occurrences per respondent per year
               (C)
Person hours per respondent per year
(C=AxB)
                         (D)
Respondents per year  [a]
                 (E)
Technical person- hours per year
(E=CxD)
                 (F)
Management person hours per year
(Ex0.05)
                  (G)
Clerical person hours per year
(Ex0.1)
                          (H)
Total Cost
Per year [b]
1.      Attend initial performance test [c]
                                      32
                                       1
                                      32
                                     0.08
                                     2.56
                                     0.13
                                     0.26
                                                                       $132.67 
2.      Repeat performance test
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
A.     Retesting preparation [d]
                                      12
                                       1
                                      12
                                       1
                                      12
                                      0.6
                                      1.2
                                                                       $621.89 
B.    Attend retesting [e]
                                      32
                                       1
                                      32
                                      0.1
                                      3.2
                                     0.16
                                     0.32
                                                                       $165.84 
3.      Litigation [f]
                                      NA
                                       
                                       
                                       
                                       
                                       
                                       
                                                                               
4.      Excess emissions  -  enforcement activities [g]
                                      32
                                       1
                                      32
                                      0.1
                                      3.2
                                     0.16
                                     0.32
                                                                        $165.84
5.      Report review
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
        Review notification of intent to construct      
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $104.00 
        Review notification of anticipated 
           commencement of construction      
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $104.00 
        Review notification of anticipated startup     
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $104.00 
        Review notification of actual startup     
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $104.00 
        Review notification of types of waste 
            to be combusted      
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $104.00 
        Review notification of HMIWI capacity     
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $104.00 
        Review notification of initial performance test
                                       2
                                       1
                                       2
                                       1
                                       2
                                      0.1
                                      0.2
                                                                       $103.65 
        Review notification of initial CMS demonstration
                                       2
                                       1
                                       2
                                       2
                                       2
                                      0.1
                                      0.2
                                                                        $103.65
        Review notification addressing sitting
        requirements     
                                      24
                                       1
                                      24
                                       1
                                      24
                                      1.2
                                      2.4
                                                                     $1,243.79 
        Review waste management plan  
                                       8
                                       1
                                       8
                                       1
                                       8
                                      0.4
                                      0.8
                                                                       $414.60 
        Review analysis for bag leak detection systems [h]  
                                       8
                                       1
                                       8
                                      0.7
                                      5.6
                                     0.28
                                     0.56
                                                                       $290.22 
        Review report of initial performance test [i]  
                                      54
                                       1
                                      54
                                       1
                                      54
                                      2.7
                                      5.4
                                                                     $2,798.52 
        Review report of initial CMS demonstration
                                      N/A
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
        Review annual report
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
            CMS emissions/operating parameters [j]
                                       6
                                       1
                                       6
                                       5
                                      30
                                      1.5
                                       3
                                                                     $1,554.74 
            Exceedances/malfunctions/periods for 
            which data not obtained [l]
                                       8
                                       1
                                       8
                                       1
                                       8
                                      0.4
                                      0.8
                                                                       $414.60 
            Results of performance test conducted 
                during the year [l]
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                              
                     PM, CO, HCl
                                      18
                                       1
                                      18
                                       5
                                      90
                                      4.5
                                       9
                                                                     $4,664.21 
                     Fugitive ash emissions
                                       6
                                       1
                                       6
                                       5
                                      30
                                      1.5
                                       3
                                                                     $1,554.74 
            Report of no exceedances [m]
                                       2
                                       1
                                       2
                                       4
                                       8
                                      0.4
                                      0.8
                                                                       $414.60 
            Report of annual control equipment inspection [n]
                                       4
                                       1
                                       4
                                       5
                                      20
                                       1
                                       2
                                                                      $1,036.49
            Review semiannual report of exceedances/
                malfunctions/periods for which data not 
            obtained [k,] [o]
                                       8
                                       1
                                       8
                                       1
                                       8
                                      0.4
                                      0.8
                                                                       $414.60 
TOTAL ANNUAL BURDEN AND COST (rounded)
 
 
 
 
                                      371
                                                                       $16,717 

[a] We have assumed that the average number  of sources that will be subject to the standard will be 5.  There will be one additional new source per year that will become subject to the rule over the three-year period of this ICR 
[b] This ICR uses the following labor rates: Managerial $62.27 (GS-13, Step 5, $38.92 + 60%); Technical $46.21 (GS-12, Step 1, $28.88 + 60%); and Clerical $25.01 (GS-6, Step 3, $15.63 + 60%).  These rates are from the Office of Personnel Management (OPM), 2012 General Schedule, which excludes locality rates of pay.  The rates have been increased by 60 percent to account for the benefit packages available to government employees.  
[c] We assume EPA personnel attend 8 percent of the initial performance tests.
[d] We assume that 20  percent will fail the initial performance test, and will have to repeat the performance test. 
e We assume 10 percent of re-tests are attended by EPA personnel. 
[f] This ICR does not account for litigation costs.   
[g] We assume 10 percent of the affected facilities are required to re-test as a result of excess emissions, and that EPA personnel attend 10 percent of these tests. 
[h] We assume only new large and medium sources will install baghouses. 
I We assume 6 person-hours per report per pollutant. For the three new HMIWI, nine pollutants are required to be tested. 
[j] We assume 1 person-hour per report per CMS. For HMIWI, assume each uses six CMS (flue gas temperature, secondary chamber temperature, charge weight, scrubber liquor pH, scrubber liquor flow, and scrubber energy input). 
[k] We assume 20 percent of the affected facilities with recurrent burden will report monitoring exceedances. 
[l] We assume 6 person-hours per report per pollutant.  For annual tests, there are three pollutants (PM, CO, and HCl) for all HMIWI. 
[m] We assume 80 percent of the affected facilities with recurrent burden will report no excess emissions. 
[n] We assume it will take 4 hours to review the annual control equipment inspection report. 
[o] Because the semiannual report coincides once each year with the annual report and both reports include information on exceedances, malfunctions, and periods for which data were not obtained, the frequency of semiannual report is shown in the table as only once per year to avoid double-counting. 

